The Recall Desk
Agency classClass IOur severity:SevereFDA (Drugs)·D-0615-2021·Announced 2021-04-21

Novo Nordisk Recalls Insulin Diluting Medium Due to Temperature Abuse

Novo Nordisk is recalling specific samples of Insulin Diluting Medium for NovoLog because they were stored below 32°F, potentially causing lack of efficacy and damage to the cartridge and pen-injectors.

The agency’s classification

FDA (Drugs): Class I

Class I is a situation in which there is a reasonable probability that the use of or exposure to a violative product will cause serious adverse health consequences or death.

This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work

What this means for you

Our assessment, not the agency’s: severity 4/5 (Severe).

The hazard poses a serious risk of illness, injury, or structural failure. Stop using the product immediately and contact the manufacturer for a refund or repair.

Our severity reasoning: The agency classification is FDA Class I, which mandates a minimum severity score of 4 per the rubric, as it represents a reasonable probability of serious adverse health consequences or death due to lack of efficacy in a critical medication.

Plain-English summary

Novo Nordisk Inc. is recalling specific samples of INSULIN DILUTING MEDIUM FOR NOVOLOG (WATER INJECTION). The affected product is the NovoLog FlexPen (insulin aspart) Injection, 100 units/mL, 3 mL Prefilled Insulin Syringe pen, Sample. The specific lot code is KS6BS11 with an expiration date of 11/30/2021. The product is distributed nationwide in the USA.

The recall was initiated because the product samples were stored at temperatures below 32°F, which does not comply with storage requirements. This temperature abuse could cause a lack of efficacy and damage to the cartridge and pen-injectors.

Consumers and healthcare providers should check their inventory for the specific lot code KS6BS11 and expiration date 11/30/2021. If the product matches these details, it should be removed from use and returned to the distributor or manufacturer according to standard recall procedures.

The recalled product

Product
INSULIN DILUTING MEDIUM FOR NOVOLOG (WATER INJECTION)
Brand
INSULIN DILUTING MEDIUM FOR NOVOLOG
Manufacturer
Novo Nordisk Inc
Category
Drug — Insulin
Hazard

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (2)

  • KS6BS11
  • Exp 11/30/2021

Distribution

Distributed nationwide across the United States.

Part of a larger recall action

This product is one of 13 recalled by Novo Nordisk Inc under a single FDA (Drugs) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.

See all 13 products in this recall →

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